MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 38MM; PROSTHESIS, TRAUMA

Catalog Number 814550038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02358, 0001825034-2020-02360, 0001825034-2020-02361.Concomitant medical products: part#: 814509180, lot#: 661770.Part#: 814510115, lot#: vk1121315c.Part#: 814501105, lot#: th1211305c.Part#: 903003004, lot#: unk.Part#: 211201505, lot#: unk.Part#: 211201405, lot#: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is not available to be returned per hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the initial surgery was approximately two (2) months ago.At the three (3) week check-up, surgeon was satisfied with follow up films.Approximately one (1) month post-implantation, obese patient fell and apparently "hobbled" on it for five (5) days before being removed.All implants were intact.Surgeon implanted a total hip because the lag screw penetrated through the femoral head (ie.Cut out).

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.It was reported the lag screw penetrated through the femoral head and all other implants remained intact.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CORTICAL BONE SCR 5.0MM X 38MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10153506
• MDR Text Key: 196201551
• Report Number: 0001825034-2020-02359
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868039492
• UDI-Public: (01)00887868039492
• Combination Product (y/n): N
• PMA/PMN Number: K111444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 814550038
• Device Lot Number: M18817A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 126